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Management of advanced/metastatic disease

Text update

In the randomised, double-blind, placebo-controlled, phase III RADIANT-4 trial, 302 patients with advanced, progressive, well-differentiated, non-functional neuroendocrine tumours of lung or gastrointestinal origin were randomised in a 2:1 ratio to everolimus 10 mg per day orally or placebo, both with supportive care. The primary endpoint was progression-free survival (PFS), while overall survival (OS) and quality of life were secondary endpoints. Median PFS was 11.0 months (95% CI 9.2–13.3) in the everolimus group and 3·9 months (3.6–7.4) in the placebo group (hazard ratio [HR] 0.48 [95% CI 0.35–0.67], p<0·00001). Although not statistically significant, the results of the first pre-planned interim OS analysis indicated that everolimus might be associated with a reduction in the risk of death (HR 0.64 [95% CI 0.40–1.05], one-sided p=0.037). Grade 3 or 4 drug-related adverse events were infrequent and manageable, though more numerous in the everolimus group.

Recommendation

In patients with unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin with progressive disease, everolimus, as compared with placebo, is associated with a statistically and clinically significant improvement in PFS.In the absence of mature OS and quality of life data, the observed PFS benefit is associated with an ESMO Magnitude of Clinical Benefit Scale (MCBS) score of 3.